FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Stent, Carotid
PMA: P140026
·
Supplement: S032
·
Decision Oct 23, 2025
Classifications
1
FEI Numbers
0
Registration Numbers
0
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Basic Information
- Device Name
- Stent, Carotid
- Trade Name
- ENROUTE® Transcarotid Stent System
- PMA Number
- P140026
- Supplement Number
- S032
- Device Class
- FDA Class 3
- Product Code
- NIM
- Generic Name
- Stent, carotid
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- October 23, 2025
- Date Received
- September 29, 2025
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
to transfer post-laser manufacturing processes of the stent component from Confluent in Fremont, California, to Confluent in Costa Rica
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NIM | Stent, Carotid | FDA class 3 | Unknown |